JCN · Class II · 21 CFR 864.8625

FDA Product Code JCN: Control, Cell Counter, Normal And Abnormal

Leading manufacturers include Streck Laboratories, Inc., R&D Systems, Inc. and Baker Instructions Corp..

12
Total
12
Cleared
47d
Avg days
1982
Since

FDA 510(k) Cleared Control, Cell Counter, Normal And Abnormal Devices (Product Code JCN)

12 devices
1–12 of 12
Cleared Nov 30, 1999
PARA TECH PLUS RETICS
K993825
Streck Laboratories, Inc.
Hematology · 18d
Cleared Jun 16, 1994
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
K942209
Bio-Rad
Hematology · 42d
Cleared Dec 06, 1993
CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE
K934497
R&D Systems, Inc.
Hematology · 83d
Cleared May 28, 1991
STAK-CHEX
K911582
Streck Laboratories, Inc.
Hematology · 50d
Cleared Aug 22, 1990
TRI-COUNT 16
K902389
Hematronix, Inc.
Hematology · 84d
Cleared Aug 22, 1990
CELL-DYN 3000 CONTROL
K902391
Unipath , Ltd.
Hematology · 84d
Cleared May 30, 1990
PARA 12 PLUS
K901875
Streck Laboratories, Inc.
Hematology · 34d
Cleared Nov 09, 1989
PARA TECH FOR TECHNICON H-1
K896154
Streck Laboratories, Inc.
Hematology · 16d
Cleared Oct 06, 1989
HEMATOLOGY CONTROL
K895373
Medical Specialties Intl., Inc.
Hematology · 38d
Cleared Apr 11, 1989
QBC(R) CENTRIFUGAL HEMATOLOGY CONTR/MULTI MODIFIED
K891907
R&D Systems, Inc.
Hematology · 15d
Cleared Dec 30, 1987
CBC-TECH(TM) HEMATOLOGY CONTROL/MULTIPLE
K874386
R&D Systems, Inc.
Hematology · 65d
Cleared Jul 30, 1982
HAEM-C PLUS BLOOD REFERENCE CONTROLS
K821956
Baker Instructions Corp.
Hematology · 30d

About Product Code JCN - Regulatory Context